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Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects

2014-08-27 03:19:23 | BioPortfolio

Summary

Obesity is an important public health problem in the United States. The investigators hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation, and reduction in body weight. This protocol is designed to study the effects and safety of gastric BTA injections. Subjects are randomized to receive placebo or one of two different doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric intake are recorded before and after injections, and subjects are seen in follow-up for 24 weeks.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Obesity

Intervention

Botulinum Toxin Type A, Placebo (normal saline)

Location

Mayo Clinic
Rochester
Minnesota
United States
55905

Status

Recruiting

Source

Mayo Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:23-0400

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PubMed Articles [15360 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type G. Though it has been isolated from soil, no outbreaks involving this type have been recognized.

Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type C which is neurotoxic to ANIMALS, especially CATTLE, but not humans. It causes dissociation of ACTIN FILAMENTS.

Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type D which is neurotoxic to ANIMALS, especially CATTLE, but not humans.

Subtype of CLOSTRIDIUM BOTULINUM that produces BOTULINUM TOXIN TYPE A which is neurotoxic to humans and animals.

Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type E which is neurotoxic to humans and animals.

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